CD Horizon® Spinal System
Tray 7064907 Cdhl II 4.75 CCM+ ROD Upper
5manufacturers in China registered for this device type
39catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| 510(k) | K190840 |
| Record published | 2022-12-30 |
| Record revised | 2022-09-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7064916 | In distribution | |
| 778001109 | In distribution | |
| 59329013 | In distribution | |
| 7050534R | In distribution | |
| 59329007 | In distribution | |
| 7064907 | In distribution | |
| 59329015 | In distribution | |
| 9010014640 | In distribution | |
| 9010014641 | In distribution | |
| 59329002 | In distribution | |
| 9010014642 | In distribution | |
| 59329011 | In distribution | |
| RBT5598947 | In distribution | |
| 5598946 | In distribution | |
| 59329008 | In distribution | |
| 7043120 | In distribution | |
| 9010014643 | In distribution | |
| 59329020 | In distribution | |
| 5332028 | In distribution | |
| 7059220R | In distribution | |
| 59329001 | In distribution | |
| 8390315R | In distribution | |
| 59329017 | In distribution | |
| 59329021 | In distribution | |
| 778001136 | In distribution | |
| RBT5598948 | In distribution | |
| 59329010 | In distribution | |
| 59329012 | In distribution | |
| 105-129R | In distribution | |
| 59329009 | In distribution | |
| 5598933 | In distribution | |
| 59329005 | In distribution | |
| 59329018 | In distribution | |
| 59329004 | In distribution | |
| RBT5598949 | In distribution | |
| 778001108 | In distribution | |
| 59329000 | In distribution | |
| 778001107 | In distribution | |
| 59329014 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.